ASTEPRO ALLERGY از شرکت BAYER HLTHCARE

اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است

ASTEPRO ALLERGY از شرکت BAYER HLTHCARE

New Drug Application (NDA): 213872

Company: BAYER HLTHCARE

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ASTEPRO ALLERGY AZELASTINE HYDROCHLORIDE 0.2055MG/SPRAY SPRAY, METERED;NASAL Over-the-counter

None

Yes Yes
CHILDREN’S ASTEPRO ALLERGY AZELASTINE HYDROCHLORIDE 0.2055MG/SPRAY SPRAY, METERED;NASAL Over-the-counter

None

Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/17/2021 ORIG-1 Approval

Type 8 – Partial Rx to OTC Switch

STANDARD

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213872Orig1s000Lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213872Orig1s000ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/17/2021 ORIG-1 Approval

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213872Orig1s000Lbl.pdf

ASTEPRO ALLERGY

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

SPRAY, METERED;NASAL; 0.2055MG/SPRAY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
ASTEPRO ALLERGY AZELASTINE HYDROCHLORIDE 0.2055MG/SPRAY SPRAY, METERED;NASAL Over-the-counter Yes 213872 BAYER HLTHCARE
CHILDREN’S ASTEPRO ALLERGY AZELASTINE HYDROCHLORIDE 0.2055MG/SPRAY SPRAY, METERED;NASAL Over-the-counter Yes 213872 BAYER HLTHCARE

CHILDREN’S ASTEPRO ALLERGY

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

SPRAY, METERED;NASAL; 0.2055MG/SPRAY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
ASTEPRO ALLERGY AZELASTINE HYDROCHLORIDE 0.2055MG/SPRAY SPRAY, METERED;NASAL Over-the-counter Yes 213872 BAYER HLTHCARE
CHILDREN’S ASTEPRO ALLERGY AZELASTINE HYDROCHLORIDE 0.2055MG/SPRAY SPRAY, METERED;NASAL Over-the-counter Yes 213872 BAYER HLTHCARE
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